Early breast cancer suitable for breast conserving surgery Cancer Malignant neoplasm of breast
Conditions
Interventions
Registration of patients selected for this treatment
collecting data regarding safety and toxicity on patients who have had treatment with TARGIT.
Sponsors
University College London (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Recommended treatment by Multi-Disciplinary Team (MDT) 2. Consent has been obtained for data to be collected
Exclusion criteria
Exclusion criteria: Under 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcomes will be measured over short and long terms. Outcome measures will include effectiveness and safety, assessed in various cohorts of patients. Core outcomes will be used for effectiveness. In addition, 'true recurrence' (basically, ipsilateral breast tumor recurrence at the same site as the original primary) will be used as defined by Recht. Safety outcomes will be based on Common Toxicity Criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Budget impact analysis of IORT in subgroups of patients will be assessed. This amounts to using cost data to calculate the mean incremental (or extra) cost per person treated using intraoperative radiotherapy (IORT) versus external beam radiotherapy (EBRT) and mastectomies (where IORT could have been given instead) and then multiplying this by the total patients eligible nationally for IORT, to calculate the total expected budget impact on the NHS if IORT in these subgroups was rolled out nationally. | — |
Countries
Australia, Canada, Denmark, England, France, Germany, Italy, Norway, Poland, Switzerland, United Kingdom, United States of America
Outcome results
None listed